IMPORTANT NOTICE
Information from clinical trials is available at this time to support the use of COVID-19 vaccine, mRNA, bivalent (Pfizer-BioNTech) to prevent COVID-19.
The FDA has approved an EUA for the COVID-19 vaccine, mRNA, bivalent (Pfizer-BioNTech) for individuals 6 months of age or older who have not received any previous COVID-19 vaccine, to be given as:
- a 3-dose series for individuals 6 months through 5 years given at 0, 3 weeks and then at least 8 weeks after the second dose
- a single dose for individuals 5 through 64 years of age
- a single dose for individuals 65 years of age and older with an additional dose 4 months or more later
The FDA has also approved an EUA for the COVID-19 vaccine, mRNA, bivalent (Pfizer-BioNTech) for individuals 6 months through 4 years of age who have previously been vaccinated against COVID-19 with COVID-19, mRNA, monovalent (Pfizer-BioNtech) (no longer authorized for use in the United States) to be given as one dose at least 3 weeks after the COVID-19, mRNA, monovalent dose followed by another dose at least 8 weeks later. If the individual had received more than 1 dose of the previous vaccine, at least two months should pass since the last dose before the COVID-19, mRNA, bivalent is given.
The FDA has also approved an EUA for the COVID-19 vaccine, mRNA, bivalent for individuals 5 years of age and older who have previously been vaccinated with 1 or more dose of any monovalent COVID-19 vaccine given as a single dose at least 2 months after their last dose of the monovalent COVID-19 vaccine. For individuals over 65 years of age, one additional dose may be given at least 4 months after the first dose of COVID-19, mRNA, bivalent vaccine.
Talk to your doctor or vaccine provider about the risks and benefits of receiving this medication.
What is COVID-19?
COVID-19 disease is caused by a coronavirus called SARS-CoV-2. You can get COVID-19 through contact with another person who has the virus. It is predominantly a respiratory (lung) illness, but it can also affect other organs. People with COVID-19 have had a wide range of symptoms reported, ranging from mild symptoms to severe illness leading to death. Symptoms may appear 2 to 14 days after exposure to the virus. Symptoms may include: fever, chills, cough, shortness of breath, fatigue, muscle or body aches, headache, loss of taste or smell, sore throat, congestion, runny nose, nausea, vomiting, or diarrhea.
How is the COVID-19, mRNA, bivalentvaccine (Pfizer-BioNTech) given?
The COVID-19 mRNA, monovalent and bivalent vaccines will be given to you as an injection into the muscle.
What should you tell the person who is giving the vaccine?
Tell your vaccine provider about all of your medical conditions, including if you:have any allergies.
have had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart).
have a fever.
have a bleeding disorder or are taking a blood thinner such as warfarin (Coumadin, Jantoven).
have a weakened immune system or are on a medicine that affects your immune system.
are pregnant or plan to become pregnant.
are breast-feeding.
have received another COVID-19 vaccine.
have ever fainted in association with an injection.
have had a severe allergic reaction after a previous dose of this vaccine.
have had a serious allergic reaction to any ingredient in this vaccine.
What are the benefits of the Pfizer-BioNTech COVID-19 vaccine?
In an ongoing clinical trial, the COVID-19, mRNA, bivalent vaccine (Pfizer-BioNTech) has been shown to prevent COVID-19 against the two known circulating strains of the virus (original and Omicron). How long you are protected against COVID-19 is currently unknown.
What are the risks of the Pfizer-BioNTech COVID-19 vaccine?
Side effects that have been reported with the Pfizer-BioNTech COVID-19 vaccine include:non-severe allergic reactions such as rash, itching, hives, or swelling of the face
injection site pain, swelling, and redness
tiredness
headache
muscle pain
chills
joint pain
fever
nausea
feeling unwell
swollen lymph nodes
decreased appetite
diarrhea
vomiting
arm pain
fainting at the time you receive your injection
There is a remote chance that the Pfizer-BioNTech COVID-19 vaccine could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to one hour after getting a dose of the Pfizer-BioNTech COVID-19 vaccine.
Signs of a severe allergic reaction can include:difficulty breathing
swelling of your face and throat
a fast heartbeat
a bad rash all over your body
dizziness and weakness
Myocarditis and pericarditis have occurred in some people who have received the Pfizer-BioNTech COVID-19 vaccine, more commonly in males under 40 years of age than among females and older males. In most of these people, symptoms began within a few days after getting the second dose of the Pfizer-BioNTech COVID-19 vaccine. The chance of having this occur is very low.
You should seek medical attention right away if you have any of the following symptoms after receiving the Pfizer-BioNTech COVID-19 vaccine:chest pain
shortness of breath
feelings of having a fast-beating, fluttering, or pounding heart
These may not be all the possible side effects of the Pfizer-BioNTech COVID-19 vaccine. Serious and unexpected side effects may occur. Pfizer-BioNTech COVID-19 vaccine is still being studied in clinical trials.
What should I do about side effects?
What you should do about side effects:If you experience a severe allergic reaction, call 9-1-1, or go to the nearest hospital.
Call the vaccination provider or your healthcare provider if you have any side effects that bother you or do not go away.
Report vaccine side effects to FDA/CDC Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is
1-800-822-7967 or report online to https://vaers.hhs.gov/reportevent.html . Please include either "COMIRNATY (COVID-19 Vaccine, mRNA)", "Pfizer-BioNTech COVID-19 Vaccine EUA", or "Pfizer-BioNTech COVID-19 Vaccine, Bivalent EUA" as appropriate, in the first line of box #18 of the report form.In addition, you can report side effects to Pfizer Inc. at http://www.pfizersafetyreporting.com or at
1-800-438-1985 .You may also be given an option to enroll in v-safe. V-safe is a new voluntary smartphone-based tool that uses text messaging and web surveys to check in with people who have been vaccinated to identify potential side effects after COVID-19 vaccination. V-safe asks questions that help CDC monitor the safety of COVID-19 vaccines. V-safe also provides second-dose reminders if needed and live telephone follow-up by CDC if participants report a significant health impact following COVID-19 vaccination. For more information on how to sign up, visit: http://www.cdc.gov/vsafe .
What if I am immunocompromised?
Certain children between the ages of 6 months and 4 years who are considered immunocompromised (have a weakened immune system), may receive a fourth dose of the Pfizer-BioNTech COVID-19 vaccine at least 1 month after the 3rd dose of either the monovalent or bivalent form of COVID-19, mRNA vaccine. For individuals 5 years of age and older considered immunocompromised, a single additional dose of COVID-19 vaccine, mRNA, bivalent may be administered at least 2 months following the initial dose.
Will the Pfizer-BioNTech COVID-19 vaccine give me COVID-19?
No. The Pfizer-BioNTech COVID-19 vaccine does not contain SARS-CoV-2 and cannot give you COVID-19.
Keep your vaccination card
When you get your first dose, you will get a vaccination card to show you when to return for your next dose(s) of Pfizer-BioNTech COVID-19 vaccine. Remember to bring your card when you return.
Where will my vaccination information be recorded?
The vaccination provider may include your vaccination information in your state/local jurisdiction's Immunization Information System (IIS) or other designated system. This will ensure that you receive the same vaccine when you return for your next dose of Pfizer-BioNTech COVID-19 vaccine. For more information about IISs visit: https://www.cdc.gov/vaccines/programs/iis/about.html.
How can I learn more?
You can learn more by:Ask the vaccination provider.
Visit CDC at https://www.cdc.gov/coronavirus/2019-ncov/index.html .
Visit FDA at http://bit.ly/3qI0njF .
Contact your local or state public health department.
Can I be charged an administration fee for receiving the COVID-19 vaccine?
No. At this time, the provider cannot charge you for a vaccine dose and you cannot be charged an out-of-pocket vaccine administration fee or any other fee if only receiving a COVID-19 vaccination. However, vaccination providers may seek appropriate reimbursement from a program or plan that covers COVID-19 vaccine administration fees for the vaccine recipient (private insurance, Medicare, Medicaid, HRSA COVID-19 Uninsured Program for non-insured recipients).
Where can I report cases of suspected fraud?
Individuals becoming aware of any potential violations of the CDC COVID-19 Vaccination Program requirements are encouraged to report them to the Office of the Inspector General, U.S. Department of Health and Human Services, at 1-800-HHS-TIPS or TIPS.HHS.GOV.
What is the Countermeasures Injury Compensation Program
The Countermeasures Injury Compensation Program (CICP) is a federal program that may help pay for costs of medical care and other specific expenses of certain people who have been seriously injured by certain medicines or vaccines, including this vaccine. Generally, a claim must be submitted to the CICP within one year from the date of receiving the vaccine. To learn more about this program, visit http://www.hrsa.gov/cicp/ or call 1-855-266-2427.
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS ® Patient Medication Information™. © Copyright, 2023. The American Society of Health-System Pharmacists ® , 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.
Selected Revisions: May 15, 2023.